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    GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

    GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

    This week, Phispers brings to you the details of the bioelectronics firm formed by GSK and Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli Lilly, besides two other news snippets pertaining to the FDA -- while the first one pertains to generic approvals, the other one relates to an additional black box warning on a few antibiotics.   GSK and Google join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life Sciences and GSK will together contribute US $ 715.12 million over seven years to the startup Galvani Bioelectronics. The startup will develop miniature electronic implants for the treatment of asthma, diabetes and other chronic conditions. The implantable devices developed by Galvani, which is owned 55 percent by GSK and 45 percent by Verily, can modify electrical nerve signals. The aim is to modulate irregular or altered impulses that occur in many illnesses.The new company will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK has been working on bioelectronic medicines since 2012 in a push to develop new patentable treatments, since its Advair respiratory treatment faces competition from generic versions. It has invested US $50 million in a venture capital fund for bioelectronics and provided funding to scientists working in the field.  Teva divests 79 products to 11 generic players to close Allergan dealTeva Pharmaceutical Industries – the world’s largest generics drug company – won a US anti-trust approval to purchase Allergan's generics business, after agreeing to divest 79 generic drugs to rival firms. This was arrived at to settle Federal Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The companies that have acquired the divested products are Mayne Pharma Group, Impax Laboratories, Dr Reddy’s Laboratories, Sagent Pharmaceuticals, Cipla Limited, Zydus Worldwide DMCC, Mikah Pharma, Perrigo Pharma International, Aurobindo Pharma USA, Prasco and 3M Company. Eli Lilly CEO steps down; company under probe by US Justice Department Eli Lilly CEO John Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter has been the company's CEO since April 1, 2008, and the chairman of its board of directors since January 1, 2009.The announcement has come at a time when Eli Lilly has been asked by the Justice Department to disclose information on relationships with pharmacy benefits managers (PBMs), the companies that negotiate prices and set reimbursement conditions.It has not been clear what exactly the department of justice is looking for. In the past, drug makers such as Novartis and AstraZeneca have agreed to pay fines and penalties to settle allegations pertaining to PBMs.  FDA continues to race ahead with generic approvals  The American regulator has reduced its pile of ANDA (abbreviated new drug applications) by about 500 applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This news comes after Bloomberg reported last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass had reported last week that Indian companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark  In regulatory news from across the world, Jinan Jinda, a Chinese API manufacturer that had failed an inspection by Italian regulators in June 2015, had more bad news awaiting it a year on. In a June 2016 re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In the June 2015 inspection, the critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall.Meanwhile, the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements.  Another black box warning added to antibiotics like Cipro and LevaquinThe FDA has upgraded warnings on certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck’s Avelox. The FDA had added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed. In May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has said it plans to build a new pipeline of drugs. It plans to revamp its research operations at the cost of around US $ 727 million..  The company also plans to close some of its R&D operations in the UK. Takeda is beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement. 

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    https://www.pharmacompass.com/radio-compass-blog/gsk-google-form-first-bioelectronics-firm-11-generic-companies-benefit-from-the-teva-allergan-deal

    #Phispers by PHARMACOMPASS
    04 Aug 2016
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    Sandoz, Mylan, Hetero, Lupin face the heat due to data manipulation at Semler

    Sandoz, Mylan, Hetero, Lupin face the heat due to data manipulation at Semler

    In April 2016, the US Food and Drug Administration (FDA) came down heavily on Semler Research Center over issues of data manipulation. The FDA had told drug firms that their applications seeking approvals on the basis of studies done by the Bangalore-based firm will not be accepted. It had also asked firms to furnish additional clinical research from other approved entities to get the FDA nod.The action had been taken as a result of an inspection of Semler's bioanalytical facility in Bangalore conducted between September 29, 2015, and October 9, 2015. Generics relying on data from Semler are not considered equivalent to the brand The FDA also changed the therapeutic equivalence (TE) rating in the Orange Book (also called the Approved Drug Product with Therapeutic Equivalence Evaluations) for any approved ANDA that relied on data from Semler to “BX.” A BX rating indicates that data reviewed by the agency are insufficient to determine therapeutic equivalence, i.e., substitutability, of the generic product to the drug it references.As drug regulators across the world invalidate clinical studies conducted at Semler Research that demonstrate equivalence of the generic drugs to branded products, PharmaCompass brings to you the impact of this scandal on various products and drug companies.  Dr. Reddy’s generic Nexium gains as competitor gets impactedThe violations uncovered at Semler Research have impacted the global generic pharmaceutical business. While most companies have been adversely impacted by the Semler data integrity scandal, there are some that have gained as well. For instance, Dr. Reddy’s North American business has got an unanticipated sales boost due to the issues at Semler. This was because the FDA mandated that competitor Hetero’s generic Nexium (an acid reflux medication) repeat its bioequivalence trials to be considered as an equivalent generic of the brand drug. This reclassification of Hetero’s drug has increased market share gains for Dr. Reddy’s Esomeprazole Magnesium – a generic equivalent of Nexium launched in the US in September last year. 96 European marketing authorizations to get impactedPharmaCompass’ assessment has uncovered 96 marketing authorizations in Europe for which “clinical and bioanalytical parts of the bioequivalence studies were performed at the Semler Research Center (SRC)”. Of these, 20 marketing authorizations are in France alone, followed by 10 each in Germany, the Netherlands and the United Kingdom. Click here to receive your copy of the European Marketing Authorizations Landscape due to the data-integrity violations at Semler  A marketing authorization application is an application submitted by a drug manufacturer seeking permission to bring a newly developed medicine or a medicinal product to the market.In all probability, the maximum fallout of the Semler episode will be on Sandoz, as 29 marketing authorizations of Sandoz are likely to be recommended for repeat studies by authorities. Other generic majors who will possibly repeat studies are Mylan (15 marketing authorizations), Teva (nine marketing authorizations), Ratiopharm (six marketing authorizations) and Venipharm (five marketing authorizations). Changes in therapeutic status of Hetero, Lupin’s drugsWhile Hetero has to repeat its studies for generic Nexium in the United States, six Hetero filings in Europe have been listed by authorities for which the clinical studies were conducted at Semler.In the United States, the FDA has also changed the therapeutic status of Hetero’s Losartan Potassium along with Lupin’s filing for the same product to one (i.e. BX) where the product is no longer considered equivalent to the brand. Lupin’s Azithromycin, Upsher-Smith’s Propranolol Hydrochloride and Unique Pharma’s Tinidazole are other products which have seen their therapeutic code category get changed (to one of not being bioequivalent) by the FDA in the past month.Click here to receive your copy of the European Marketing Authorizations Landscape due to the data-integrity violations at Semler WHO questions findings of Semler studiesWhile the FDA and European regulators are busy dealing with the aftermath of the problems at Semler, the World Health Organization (WHO) has also been very active. In the Notice of Concern (NOC) issued by the WHO to Semler, as an outcome of WHO’s own inspections and discussions, Semler acknowledged that “four FDA studies and one WHO study have questionable data”. The WHO recommended “an immediate stop for all submissions of dossiers relying in whole or in part on involvement from Semler”. The WHO has questioned the findings of 11 studies performed at Semler for products which meet WHO’s pre-qualification criteria. The studies were performed on behalf of Mylan (three studies), Lupin (five studies), Micro Labs (one study) and Strides Ltd (two studies). Additionally, the WHO has also revealed 12 studies for which the products are currently under assessment but not yet pre-qualified.   Our viewSemler’s data integrity concerns have made drug regulators question the equivalency of over 110 generic drug applications. Concerns have been highlighted by the FDA, European Medicines Agency (EMA) and the WHO. And the steps taken by the regulators indicate the magnitude of the fallout of these inspections. For the generic pharmaceutical industry, life has become a lot more challenging. In addition to concerns about in-house manufacturing compliance problems, they also need to worry about data integrity issues at clinical research firms. Clinical trial falsification issues at the laboratories of Quest Life Sciences, GVK Biosciences, Alkem Laboratories and Semler indicate that a sustained supply of generics can no longer be taken for granted.Click here to receive your copy of the European Marketing Authorizations Landscape due to the data-integrity violations at Semler    

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    https://www.pharmacompass.com/radio-compass-blog/sandoz-mylan-hetero-lupin-face-the-heat-due-to-data-manipulation-at-semler

    #Phispers by PHARMACOMPASS
    02 Jun 2016
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    The silver lining in Ipca’s Import Alert blues

    The silver lining in Ipca’s Import Alert blues

    Ipca Laboratories finished dosage facilities at Silvasa and Pithampur (India) were put on the FDA Import Alert List this week, an outcome of Ipca running into problems in yet another FDA inspection. The latest alert comes after Ipca’s API facility in Ratlam (India) was banned from exporting to the U.S. in January this year. However, when reviewing the details of Ipca’s alert, is there a business opportunity which can be capitalized upon? The FDA Import Alert, while banning all imports from the Pithampur facility, has stopped everything coming out of the Silvasa plant except Hydroxychloroquine Sulfate & Propranolol Hydrochloride. Ipca’s Ratlam facility had received a similar exemption earlier for the following APIs: Sulfamethoxazole, Trimethoprim, Ondansetron, Hydroxychloroquine Sulfate, Propranolol Hydrochloride and Furosemide. Given all the details that have been published about the observations at Ipca’s various facilities, a complete shutdown of all imports into the U.S. would have been expected.   Why did a few of Ipca’s products get an FDA import alert exemption? Business Standard reported, at the time of covering the initial Ratlam ban that “Given the acute shortage in the US, the FDA, however, has exempted four APIs from the import ban.” The article also mentions the market growth of Hydroxychloroquine from $30 million to $120 million in the last few years. While the FDA hasn’t yet put Hydroxychloroquine on their drug shortage list, concerns regarding supply disruption are already being felt. Wyeth’s branded Propranolol Hydrochloride was a $215 million product in 2006, before intense generic competition reduced the market to about 10% of its original size in less than two years. While almost every major generic company has some variant of Propranolol Hydrochloride on the market, the number of API suppliers are extremely limited. Pharma Compass’ database shows that as Ipca, Albemarle (USA) and Cosmo Spa (Italy) are the only active Drug Master Files in the FDA database, capacity expansion constraints in Europe and United States could provide an opportunity for compliant API manufacturing of Propranolol Hydrochloride.  With API manufacturers looking for new horizons, Ipca’s exemptions of old products like Sulfamethoxazole, Trimethoprim, Ondansetron, Hydroxychloroquine Sulfate, Propranolol Hydrochloride and Furosemide should provide an manufacturing and marketing opportunity worth examining. Search our database for Sulfamethoxazole, Trimethoprim, Ondansetron, Hydroxychloroquine Sulfate, Propranolol Hydrochloride and Furosemide to study the competitive landscape of manufacturers, pricing information and a lot more. 

    Impressions: 4264

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    https://www.pharmacompass.com/radio-compass-blog/the-silver-lining-in-ipca-s-import-alert-blues

    #Phispers by PHARMACOMPASS
    27 Mar 2015
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